Monthly Archives: September 2018

Fertility Drugs and Birth Defects

If you can’t trust the FDA, then who can you trust? After all, it’s part of the Federal Government and the designated watchdog to protect the consuming public from dangerous and ineffective drugs. It also sits in a position of impartiality, is loaded to the gills with expertise, and even has unlimited access to some of the foremost experts in the country, if not the world. Thus, when the FDA puts its stamp of approval on the language of the product labeling that accompanies a drug, it is something that every prescribing doctor can rely upon.

Or can they?

The official language for a drug is contained within a document referred to as a package insert. It accompanies the package of pharmaceutical products that are delivered to your local pharmacy, and contains everything a prescribing physician would want to know about a drug, including its chemical composition, pharmacology (how it works), indications (what it is intended to treat), contraindications (when it shouldn’t be given), warnings, precautions, adverse reactions (side effects) and dosage. Although it is printed by the manufacturer of the drug, by law its language must be first approved by the FDA. Most prescribing physicians rely upon what is stated about a drug within the package insert, or by referring to the Physician’s Desk Reference (PDR), an annual publication which incorporates the same approved language contained within the insert.

Consider that on November 30, 1983, the FDA approved an updated draft of the package insert for Clomid (clomiphene citrate), one of the most popular fertility drugs in the world. On that date it requested the manufacturer (Merrell Dow Pharmaceuticals, Inc.) to prepare final print labeling that included the following new warnings, which it had earlier required:

· “Some Clomid and/or its metabolites…may, therefore, remain in the body during early pregnancy in every woman who conceives in the menstrual cycle of Clomid treatment.”

· “The physician should counsel the patient with special regard to the following potential adverse reactions that may be encountered. …Pregnancy Wastage and Birth Anomalies.”

· “Among the birth anomalies spontaneously reported as individual cases since commercial availability of Clomid, the proportion of neural tube defects has been high among pregnancies associated with ovulation induced by Clomid….”

· “Population-based reports have been published on possible elevation of risk of Down’s Syndrome in ovulation induction cases and of increase in trisomy defects among spontaneously aborted fetuses from subfertile women receiving ovulation inducing drugs (no women with Clomid alone and without additional inducing drug).”

The FDA had also requested deletion of the following statement, previously included in earlier editions of the package insert: “No causative evidence of a deleterious effect of Clomid therapy on the human fetus has been seen….”

The FDA was justified in ordering these changes because: (a) Clomid has a long half-life (5 days), and studies had shown that the drug and/or its metabolites had been found in feces as long as 6 weeks after it had been ingested; (b) case reports of birth defects voluntarily submitted to the FDA by the medical profession revealed that about 25% of all reported cases involved neural tube defects (spina bifida and anencephaly); and (c) published studies had shown an increased risk in Down syndrome and abnormal chromosomes in spontaneous abortions following the use of fertility drugs, including Clomid. Such studies also represented “causative evidence of a deleterious effect of Clomid therapy on the human fetus.”

On March 5, 1987, the FDA wanted the drug company to add a further warning:

· “Clomid is contraindicated in pregnant women. Clomid may cause fetal harm when administered to pregnant women. Since there is a reasonable likelihood of the patient becoming pregnant while receiving Clomid, the patient should be apprised of the potential hazard to the fetus.”

Yet to this very day, none of these justified warnings have ever been included in the Clomid package insert. And the above statement that was requested to be deleted was never removed until 1995, when it was replaced with: “No causative evidence of a deleterious effect of Clomid therapy on the human fetus has been established….” The change is an apparent acknowledgement that such evidence had by then been “seen,” but had not reached the level of establishing a causal relationship.

But it gets worse.

The current Clomid package insert represents to every prescribing doctor:

· “The overall incidence of reported birth anomalies from pregnancies associated with maternal CLOMID ingestion during the investigational studies was within the range of that reported in published references for the general population.”

So, what is wrong with this statement? The pre-market investigational studies referred to were never designed to assess the risk of birth defects. This acknowledgement has been made under oath by the drug company’s employee who oversaw the studies. In other words, no one knows how many birth defects occurred during these studies. This is due in part because the vast majority of the clinical investigators were fertility specialists who did not deliver any of the babies. After conception was achieved, the pregnancies were delivered in other clinics by doctors who had no obligation to report the outcome. There is also evidence that some documented birth defects and spontaneous abortions from the investigational studies were not reported by the drug company to the FDA. These, and many other deficiencies, have been reported to the FDA on several occasions, including as early as July 1975.

The tragedy is that every physician who relies upon the Clomid package insert before prescribing the drug is being deceived into believing that there is absolutely no risk of the drug causing birth defects – and that every Clomid patient is being similarly deceived and denied the right to make a true informed choice. Whether or not a woman might choose to roll the dice and encounter the risk, she has every right to know what that risk is; not only what the percentages are, but the type of birth defects she might be faced with should the dice come up “snake eyes.”

But what if there was a means to substantially reduce or even eliminate that risk? What if it involved nothing more than taking a small dietary supplement during the first 8 weeks of pregnancy? Being denied such an opportunity would be the greatest tragedy of all, especially if the Clomid mother came home with a malformed baby in her arms.

The above documented facts are just a small sample of the wealth of information available on my website and in my book, THE PRICE OF OVULATION: the Truth about Fertility Drugs and Birth Defects – and a Solution to the Problem. The “solution” is explored in depth in the book, including all of the scientific studies which back up the conclusion, and which can potentially save tens of thousands of babies from severe and catastrophic congenital anomalies – even those occurring in natural pregnancies.

How To Begin to Cure Drug and Alcohol

Simply put, addiction is easy. Rehabilitation is hard. I should know. I’ve been a rehabilitation counselor for over thirty years and an addict for over fifty. That’s right, an addict. Just like you. Just like your wife or husband, mother or father. Just like your sons and daughters. An addict like your friends and neighbors, aunts and uncles, doctors and lawyers, or your cashiers and waitresses. Peace Officers, firefighters, the rich, the poor, government workers, elected officials, celebrities, sports figures–addicts us all.

Throughout my lifetime, I’ve tried about every drug on the street and most in the pharmacy. In the past, I’ve been addicted to cocaine and, as a teenager, speed. Today my addictions include the mind altering, perception bending and hard-on-the-body but perfectly legal, drugs like refined sugar and caffeine. Some of my addiction are medically related, prescribed medications (as many of you can understand) that have been given to me by my well-intending physicians. Marijuana, prescribed to me due to the adverse effects of PTSD, is such a medication.

As a student, I consumed my share of alcohol – the last real blitz in celebration of Richard Nixon’s resignation. It’s been several decades since that bleary night and I haven’t had more than a couple dozen beers or sips of wine since, so alcohol is not difficult for me to manage. But I was an addict long before I gained my postgraduate degree as a rehabilitation counselor. Knowledge does not make you immune from the foibles of addiction.

My eldest daughter, though a beautiful and talented actress, is an opiate addict. Opiate addiction among our young is a more common phenomenon than the general public would suspect. So, even years of experience dealing with drug and alcoholic patients didn’t prevent my own flesh and blood from becoming addicted to a near fatal lifestyle.

Gambling. Sex. Speed. Shopping. Your morning doughnut. An after dinner cigarette or brandy. Screens. Cell phones. MP3’s, HDTV, video games on your home PC. Electronics hypnotize and enslave millions of us as they suck up our time and money, just like opiates, while we often ignore our own family and friends.

Violence. How many of us are addicted to the many forms of violence? This listing could go on forever. Addiction is rampant and getting worse.

Addiction is and will continue to be one of the chief social concerns of the 21st Century.

How did this happen? Was it always this way? Why can’t we stop doing the things we do excessively that, most likely, we needn’t be doing at all? What is wrong with us and why does it produce so much guilt?

Holistic practitioner and author Dr. Andrew Weil once proposed that altering consciousness was an innate process. That means we have a built-in urge to see and experience things differently than we normally see them. That would certainly explain why we love to turn in fast circles as children, or roll down hills to get dizzy. It would also explain why, as we grow, the simple turning circles or rolling down hills becomes riding a roller coaster or speeding at one hundred miles per hour.

It would stand to reason this instinct we have to experience an offset reality may be the basis for alcohol consumption, drug use, and other extreme, perhaps life-threatening behaviors.

However, addiction is a human condition designed to keep us alive. Think about the attraction we have to our mother’s teat, returning again and again for the sweet milk provided with a warm and soothing touch. This natural addictive process melds with our innate need to alter perception, and it explains why these two create a very potent combination that is the precursor of all addiction.

And, we humans are great copycats. In fact, it is not too much of a generalization to say that humans simply love to copy one another. From fashion to what we read or watch, to the activities we play, humans relish in imitation. If one person has a fetching new hair style, you can bet that within a short time that new hair style wil be seen on magazine covers and televisions shows. With knock-off garments and look-alike accessories, humans copy each other as a matter of course. No wonder designer drugs catch on so quickly and addiction to these new drugs is rampant. If one person is getting high on the latest and greatest drug, you can rest assured that an entire city will be consuming that new drug within a short period of time.

Recently, I counted five out of six television commercials during an evening national newscast commercial break were ads from drug companies pushing their latest and most potent products. We are inundated by pharmacology and constantly persuaded that pills can cure our ills. This message subliminally gives us an unconscious okay to delve into drugs and the highs they provide.

Yes, addiction is easy. Rehab is hard. Can we meet this challenge?

Rehab is not for every addict. Too many of us are involved with life-threatening addictions. Some of us are in great physical peril and have gone beyond the ability to make rational choices for ourselves. These addicts need immediate intervention and treatment.

Most of us know someone who needs this sort of help. When we are so far removed from our true selves, we may need someone or some entity (government, religious, spiritual) or something to read this book for us, to help us prepare for the rigors of rehabilitation.

Causes Confusion Between Drugs and Cosmetics

With the myriad of cosmetic products on the market today how does the consumer know which promises made, in fact, are delivered. Although the FDA (Food and Drug Administration) does not have oversight over the formulation of cosmetics they do have control over the claims a manufacturer makes about their products.The FDA has very specific guidelines separating a cosmetic from a drug. If the claims a particular product makes results in a change in the structure or function of the body or if a product promises to treat or cure a condition then it is considered a drug and not a cosmetic by the FDA. Although some products appear to be cosmetics, the FDA considers them drugs. Examples of these are sunscreens and deodorants. Although on the surface they do not appear to be drugs, according to FDA guidelines they change the structure (preventing sunburn) or stop perspiration (function) and therefore, fall under the guidelines for drugs.

Once a product falls into the drug category, and this includes OTC or over the counter drugs, only ingredients approved by the FDA for use to treat a particular condition can be used to make a particular claim. The simplest example would be if I were to manufacture a cream to treat acne containing an ingredient that the FDA did not approve for the treatment of acne, then I would not be able to make the claim that my cream was an “Anti-Acne Cream”. Once a product has been defined as either a drug or an OTC, then the product label listing the ingredients must be divided in two categories, active Ingredients and inactive Ingredients. The active ingredients have to be listed in order of decreasing concentration while the inactive ingredients are listed in alphabetical order. For cosmetics where no claims should be made that might confuse the consumer into believing the product has drug properties no such separation of ingredients into the active and inactive need appear on the label. The ingredients need to only be labeled in order of decreasing concentration and not alphabetically.

The problem with most cosmetics that appear on the market today is that they make claims that would classify them as drugs and not cosmetics.The vast majority of cosmetics on the market are in clear violation of FDA guidelines but the FDA does not have the resources nor the inclination to stop this practice. Examples of cosmetics that make claims using marketing phrases like anti-wrinkle, anti-aging, removes dark circles under the eyes, reduces puffiness, thickens lips, etc., are in clear violation of the FDA. Obviously, no cosmetic exists that can stop the aging process and if a manufacture wants to sell a cream, serum, or fluid that claims to alter the structure of the body like eliminating wrinkles, spots, or dark circles than they must submit clinical studies following the same stringent rules and regulations that govern new drugs. Clearly, it is easier to make false claims then spend the millions of dollars involved in doing clinical studies and hope you do not get caught, at least not before you have made your millions.

Another area that the FDA tries to regulate is not only what the manufacturer says about a product but the impression that a product gives. The simplest example of this misinformation can be seen with sunscreens. Just look on the shelves of your local pharmacy and see sunscreen products offering SPF or sunburn protection factor as high as 70. The FDA has been grappling with how to deal with this misinformation. The consumer assumes that a sun lotion with an SPF of 30 offers twice the protection as one with an SPF of 15. This, unfortunately, is a false assumption. A sun cream with an SPF of 30 only offers an increase in sunburn protection of 3% when in comparison to one with an SPF 15. There is practically no increase in protection in sun care products with SPF’s above 30, but it sure makes for a great selling tool for products with high SPF’s.

It is up to the consumers to educate themselves and have realistic expectations from their cosmetic products. Many studies do show that the ingredients contained in certain cosmetics have a beneficial effect. If a company wants you to buy their products they should offer information on their websites a tab that provides an abstract of the clinical evidence verifying the claims that they are making. The rule of thumb should always be Caveat Emptor, let the buyer beware.

Drugs and Suicides in the Armed Forces

It is an utter disgrace that while men and women are abroad fighting for their country, corporations back in the homeland are using the stresses of their endeavours as a means to make money – moreover, they are making money by peddling bogus solutions in the form of chemicals that wreck them physically and mentally.

Finally, in January this year that particular cat was out of the bag as it became known that more of our military are dying of suicide than of combat deaths.

Why? What is so different about the current war to bring about this strange and tragic phenomenon? Who or what is having more success killing our soldiers than the enemy? After all, something or someone who kills more of our soldiers than the enemy does, is a more dangerous enemy is it not?

The answer is simple: in this war our military are being pumped full of psychiatric drugs and we now have what Time Magazine referred to as “America’s Medicated Army.”

Now, it is a well documented fact that the chemical poisons known as antidepressants and antipsychotics, with which we are “medicating” our troops cause brain and nerve damage among many other adverse effects and that if you submit an individual to much of this abuse, you will wreck him. Among some of the adverse effects the individual victim is likely to experience can be loss of impulse control, slowed reactions and various perception problems. Such debilitation’s are all potentially fatal for a soldier or airman in a combat zone so the number of personnel killed as a consequence of being drugged by their own side may be higher than anyone knows.

Among the know side effects of such drugs are suicidal thoughts and impulses and it does not take a genius to realise then that if we are medicating our soldiers on an unprecedented scale with drugs known to cause suicidal impulses and they are killing themselves at a rate faster that the enemy can manage, then the drugs are behind it.

Behind the drugs are the psychiatrists who push them, the special psychiatric units now attached to the military that dish them out and encourage their use and the manufacturers who make them and reap vast profits from their consumption by hundreds of thousands of military personnel.

There are further profits made when personnel return to the homeland, for many psychiatric drugs are designed to be addictive (more money to be made from people who can’t stop taking them) and people who begin on psychiatric medications all too often become customers of the psycho-pharmacy for life.

We all knew that the arms manufacturers were profiting from the wars that send out sons and daughters to their deaths but now, in these dark times of corporate mayhem, the drug makers are at it too.

In Vietnam, the war effort was sabotaged by drugging our soldiers with street drugs, now the sabotage has been institutionalized and the saboteurs, the pedlars of mind-altering chemicals “respectable”. Although the scale of it may be unprecedented, this is not in fact the first time that psychiatry has coiled itself around the military. The involvement dates back dates back more than 90 years.

During World War I, for example, the biggest problem the German army faced was desertions from the front lines. So the German military elite, from their chateaux and bunkers safely far behind the lines, turned to psychiatrists who presented themselves as experts.

The psychiatrists came up with the “miracle cure” of the day: electro shock, the process of searing parts of the brain with electricity (try wiring your head up to the mains!). The theory was that if the shocks soldiers experienced due to the brutalities of the war made them run away, then another shock-electricity to the brain-could get them to willingly return to combat. Stupid as this sounds, the Germans bought it and it appears to have been successful, from the point of view of the German elite at least, in so far as many soldiers chose to face the front lines rather than be tortured again by having another 450 volts of current tear through their brain.

A shabby and cruel terror tactic carried out against their countrymen it might have been but it was good enough for the German military elite (who themselves did not have to submit to it) and the love affair between the psychiatry and the military elites of various nations had begun and has continued ever since.

Today, electroshock is a discredited barbarity but the public have not yet caught on to the damage done by drugs, although recently the truth has been emerging little by little – too slowly unfortunately to have saved many lives.

In 2006, The Philadelphia Enquirer reported that drug use was an increasing problem in Iraq and at the back of this lay the fact that the medics were generously handing out prescription medications and these were being abused.

Bruce E. Levine, Ph.D., clinical psychologist and author of Surviving America’s Depression Epidemic, pointed out in February 2009, “Americans heard about a dramatic rise in suicides among U.S. soldiers.” And, sure enough, army statistics confirmed 128 suicides (with 15 more deaths under investigation), while suicides for the Marines also increased, with 41 in 2008, up from 33 in 2007 and 25 in 2006.

According to Best Syndication News (April 17, 2009), suicides among soldiers serving in Iraq were reported to be twice that of other wars, while the number of soldiers who killed themselves during January 2009 exceeded the number of soldiers who were killed by the enemy in Afghanistan and Iraq combined during the same time period.

What has changed? Our soldiers are no less courageous than the soldiers who have fought for their country in earlier wars and the conditions are bad enough but surely not worse than the conditions faced by their fathers in Vietnam. Who or what is doing this and in so doing aiding the enemy in its goal of killing our soldiers?

What has changed is the wholesale use of prescribed drugs, especially antidepressants that are worse than street drugs and known to cause suicidal thoughts and feelings. This is a new phenomenon: such a thing did not happen during other wars and in my view we are looking at what amounts to a Fifth Column activity in its effects.

Don’t take my word for just how harmful these drugs are. As long ago as March 2004, an FDA Public Health Advisory about these antidepressants, warned: “Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia [severe restlessness], hypomania [abnormal excitement, mild mania] and mania [psychosis characterized by exalted feelings, delusions of grandeur and overproduction of ideas], have been reported in adult and pediatric patients being treated with antidepressants…” It omits other known side effects of drugs: slow reaction times and distortions in perception, which of themselves place a soldier in a war zone at inordinate risk..

Dr. Levine (see above) pointed out: “While treatment for emotionally troubled soldiers increasingly consists of antidepressants such as Prozac, Paxil, and Zoloft, recent investigations show that these drugs are no more effective than placebos and can actually increase suicidality.”

However, the killing of our soldiers as a result of such medications may extend further than just suicides for they cause so many other physical complications. We have already looked at the possibility that such brain-damaging drugs could be getting soldiers killed by suppressing reaction time and other performance parameters but by way of another example, California neurologist, Dr. Fred A. Baughman, Jr. investigated a series of veterans’ deaths in 2008 and concluded they actually died from cardiac arrest induced by psychiatric drugs.

What had emerged was that all seemed “normal” when the deceased soldiers went to bed and all of them had been prescribed a cocktail of antipsychotics and tranquilizers. In January of the following year the New England Journal of Medicine seemed to back up Dr Baughman’s conclusions when it reported that antipsychotics double the risk of sudden cardiac arrest.

It was reported in June 2008 that 89% of veterans labeled with “Post Traumatic Stress Disorder” (and the unreliability and lack of clear, consistent diagnostic criteria of psychiatric labeling and the lack of scientific foundation for these “mental illnesses” are extensively reported elsewhere) are given antidepressants and 34% given antipsychotics. “A third, then, are exposed to the additive potential to cause sudden death,” Baughman concluded

Meanwhile Dr Levine adds, “In order to prevent even more suicides, both the research and basic common sense instruct is that we need less psychiatric drugs and more political courage.”

He summed up the whole flawed and inhuman psychiatric approach in a nutshell: “For many mental health professionals, especially governmental ones, a ‘good treatment outcome’ consists of a troubled person adapting to a miserable, dehumanizing environment in a way that causes the least problems for the authorities…mental health professionals are far less likely to recommend a radical altering of an environment than they are to recommend a chemical-altering of the person suffering from it.”

Drugs and Medications to Fight Alcoholism

Various treatments are available to help people with alcohol problems. Varying on the circumstances, patient treatment source may involve an evaluation, a brief lifestyle intervention, an outpatient advisory program or counsel, or a residential inpatient stay. Most of the time though, people are prescribed with drug treatment, which proved to be most effective.

Most effective Alcoholism treatment drugs:

Antabuse (medical drug name – disulfiram) is an effective and simple alcoholism treatment solution. Antabuse pills won’t cure alcoholism by itself, nor will antabuse therapy remove the urge to drink. But if you drink alcohol while on Antabuse, you will experience a severe physical reaction that includes but not limited to flushing, nausea, vomiting and headaches, and these are merely mild antabuse side effects (note that allergies to antabuse do exist as well). Since Antabuse produces this reaction only when consumed with alcohol, it is safe to use this drug as a preventive measure. Antabuse duration of use is approximately 12 hours, which is why drinking while on antabuse treatment is strictly prohibited. Even a small amount of alcohol can cause a violent reaction.

Another popular solution is ReVia (Naltrexone), a drug used to negate the narcotic high, also reduces the urge to drink. ReVia is not a cure for alcoholism, because it merely reduces the contempt to start drinking. You must be ready to change and be willing to undertake a full treatment source that includes professional medical counseling, addict support groups, and thorough medical supervision. If you positively think that ReVia will help you suppress the urge, it might just as effective alone.

The treatment options mentioned above are merely examples of the existing alcohol treatment measures. The drugs mentioned can be harmful to your health if misused or misdosed, especially antabuse. Antabuse side effects vary a lot from person to person, even death might occur. You should be absolutely sure of your health status to start medication by yourself, but we strongly advice you to consult a professional doctor to instruct you on the use of drugs and other alcoholism prevention measures.